Role of Colchicine as Anti-Inflammatory Therapy in HFpEF

NCT06837623 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2025-02-25

No results posted yet for this study

Summary

Heart failure with preserved ejection fraction (HFpEF) is a condition associated with high morbidity and mortality. Chronic low-grade inflammation plays a key role in its progression, yet few treatments specifically target this pathway.

This clinical trial aims to evaluate the effectiveness of colchicine, a well-tolerated anti-inflammatory drug, in reducing inflammation in HFpEF patients. The study will assess whether colchicine lowers levels of soluble ST2 (sST2), a biomarker linked to inflammation and cardiac stress in HFpEF.

Participants will take colchicine daily for three months, with blood samples collected at baseline and at the end of the study to measure changes in sST2 levels. The findings could provide new insights into the potential role of colchicine as a treatment for HFpEF.

Conditions

  • HFpEF - Heart Failure With Preserved Ejection Fraction

Interventions

DRUG

Colchicine Tablets

Oral colchicine tablets. The dosing regimen is as follows: * Patients weighing \>70 kg: 0.5 mg twice daily (BID) * Patients weighing ≤70 kg: 0.5 mg once daily (OD) Administered for 3 months

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Magdy Abdelhamid Abdel Aziz, Professor of Cardivascular M · Cairo University

  • Ahmed Kamal, MD in Cardiology · Cairo University

  • Nesrine M El Gharbawi, Prof of clin. & Chem Patho · Cairo University

  • Shaima M Zeyad, Cardiology Resident · Cairo University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2025-02-22
Completion
2025-03-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06837623 on ClinicalTrials.gov